Not only the state drug regulators, even the zonal offices of the Central Drugs Standard Control Organization (CDSCO) have no “harmony and uniformity of approach” when it comes to interpreting rules and regulations on any issue related to pharmaceutical sector, said Azadar Khan, senior vice president, Sun Pharmaceuticals on Monday.
In a similar vein, Rajiv Kumar Saxena, vice president, Mankind Pharma, said that since regulations are made by the Central government and implemented by the state governments, there is a big disconnect when it comes to implementing them.
Both — Saxena as well as Khan — made these statements while participating in a panel discussion at CII National Pharmaceutical Conclave in New Delhi on Monday. “Not only at the state level, but we experience that there is no harmony and uniformity of approach even at the zonal offices. So, people take their own interpretation — the zonal heads of the CDSCO — so I think there should be a kind of guideline or SOP (standard operating procedure) so that the approach of zonal offices on a particular issue should be same. This is one thing that requires the attention,” Khan said.
Khan further added that the Subject Expert Committees (SECs), which examine the proposal of new drugs and give recommendations, need to have clarity in their approach on “what is in their frame of reference and what is out of their frame of reference”. He added that changing positions of such committee does not help the industry. SECs work under the CDSCO only.
Saxena said during the panel discussion: “There is some disconnect as pharmaceuticals or healthcare is part of the concurrent list of the Union. Regulations are made by the central government while they are implemented by the state governments. So, there is a big disconnect among the interpretation of different laws. And because of these different interpretations, one manufacturer has to face different issues at different state levels.”
Khan said that Indian drug regulator should give certain exclusivity period — similar to that of the United States Food and Drug Administration — to companies that are first to file the application for launching a generic drug whenever a patent period of an exclusive drug is over. CDSCO, Sun Pharma and Mankind Pharma did not respond to the queries sent by The Indian Express.